The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease (LDN-Ped)
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Purpose
It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing endogenous enkephalin levels in subjects with active Crohn's disease. This is especially important in children who often are suffering from nutritional deprivation which retards their growth.
The key objectives are to:
- Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers, weight, and pediatric quality of life survey.
- To determine the safety and toxicity of low dose naltrexone in pediatric subjects with active Crohn's Disease.
- Assess the potential mechanism by which naltrexone exerts its action by measuring plasma opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: Naltrexone Drug: Placebo and Naltrexone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease |
- Pediatric Crohn's Disease Activity Index Score [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]Primary outcome was safety and toxicity
- IMPACT III which measures quality of life [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
Secondary outcome was effects of naltrexone on PCDAI scores from baseline to end of 8-weeks of therapy.
Other secondary outcomes were quality of Life
| Enrollment: | 14 |
| Study Start Date: | July 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
Subjects will receive placebo for for the first 2 months then be crossed over to active drug for the last 2 months
|
Drug: Placebo and Naltrexone
Subjects will receive placebo for for the first 2 months then be crossed over to active drug (Low Dose Naltrexone) for the last 2 months
|
|
Active Comparator: B
Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 4 months
|
Drug: Naltrexone
Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 4 months
|
Detailed Description:
The present proposal is designed as double-blinded placebo controlled study involving 30 children between 6-17 years of age with active Crohn's disease. Children will be treated with either naltrexone or placebo for the first 8 weeks then all subjects will receive active naltrexone drug the last 8 weeks. A one month follow-up appointment will be scheduled 4-weeks after completion of the active drug for safety and to assess Crohn's activity. Low dose naltrexone (LDN) will be dispensed in either capsules at a dose of 4.5 mg for those ages 10 years or older and in liquid form at 0.1 mg/kg for those under age of 10 or less than 45 kg. Half of the subjects in the first 8 weeks will be randomized to placebo which will be either capsules filled with avicel (see section 6.0) or diluent (flavored water) if in liquid form. Children are eligible who are not of child-bearing potential or are using two means of effective birth control, have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31 points, and have the confirmed diagnosis of Crohn's disease by either endoscopic or radiographic tests.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All subjects must give written informed consent by parent or guardian
- Male or female subjects, > 6 - 17 years
- Patients must have endoscopic or radiographic confirmed Crohn's Disease.
- Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.
Exclusion Criteria:
- Adolescent women of childbearing potential and / or sexually active unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
- Adolescent women who are pregnant or breastfeeding
- Subjects with an ostomy or ileocolic anastomosis from surgery as these operations interfere with the PCDAI assessment
- Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be discontinued 4 weeks prior to study initiation.
- Patients with abnormal liver function tests
- Prednisone greater than 10 mg or > 0.2 mg/kg orally
Contacts and Locations| United States, Pennsylvania | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: | Jill P Smith, MD | Pennsylvania State University College of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Jill P. Smith, MD, Penn State University |
| ClinicalTrials.gov Identifier: | NCT00715117 History of Changes |
| Other Study ID Numbers: | PSU-IRB-27793 |
| Study First Received: | July 14, 2008 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Penn State University:
|
children pediatric Crohn's Disease naltrexone |
LDN IBD Inflammatory bowel disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Naltrexone |
Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013